替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014867494946694942884950594945874930700.72
211.024793784860564827170.98
单位质量响应值RSD%判断
44783.8343803.721.57数据可信
供试品溶液-E43216批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.16154.950.000.16154.94
22268-22680.4610.46
3-0.0000.00
4-0.0000.00
5-0.0000.00
62333-23330.4740.47
10min1-0.0000.31178.680.000.31178.78
2-0.0000.00
32416-24160.4910.49
46688-66881.3591.36
5-0.0000.00
6-0.0000.00
15min11742-17420.3540.67103.020.350.68102.96
2-0.0000.00
38887-88871.8061.81
46050-60501.2291.24
51715-17150.3490.35
61447-14470.2940.30
20min11893-18930.3850.4124.340.390.4224.47
21822-18220.3700.37
32947-29470.5990.61
41692-16920.3440.36
52249-22490.4570.46
61626-16260.3300.33
30min14104-41040.8340.7353.350.840.7453.18
21780-17800.3620.37
37095-70951.4421.46
42437-24370.4950.51
53436-34360.6980.70
62592-25920.5270.53
45min14248-42480.8631.0331.240.871.0530.38
26654-66541.3521.36
33369-33690.6850.71
43784-37840.7690.79
57277-72771.4791.49
65179-51791.0521.06
60min16297-62971.2801.9533.491.291.9733.18
213196-131962.6822.70
310811-108112.1972.22
46368-63681.2941.32
513205-132052.6832.70
67832-78321.5921.61
极限1123979-12397925.19422.5620.1225.2122.5920.08
2117883-11788323.95523.98
3103752-10375221.08421.12
468782-6878213.97714.01
5125963-12596325.59725.63
6125804-12580425.56525.59
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014969054970804965794948484933064957440.33
211.024906304970364938330.92
单位质量响应值RSD%判断
45026.7044812.430.34数据可信
供试品溶液-F73104批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.09244.950.000.09244.95
2-0.0000.00
3-0.0000.00
42748-27480.5510.55
5-0.0000.00
6-0.0000.00
10min1-0.0000.06244.950.000.06244.95
2-0.0000.00
3-0.0000.00
41659-16590.3320.34
5-0.0000.00
6-0.0000.00
15min14224-42240.8460.22148.220.850.22147.77
2-0.0000.00
31353-13530.2710.27
41065-10650.2130.22
5-0.0000.00
6-0.0000.00
20min11233-12330.2470.2690.580.250.2790.56
2-0.0000.00
32201-22010.4410.44
43013-30130.6040.61
51483-14830.2970.30
6-0.0000.00
30min13319-33190.6650.6522.080.670.6522.36
22737-27370.5480.55
34500-45000.9020.91
43418-34180.6850.69
52815-28150.5640.57
62556-25560.5120.51
45min13045-30450.6101.4130.700.621.4230.51
27753-77531.5531.56
39377-93771.8791.89
47975-79751.5981.61
56540-65401.3101.32
67420-74201.4871.49
60min14647-46470.9312.6343.650.942.6543.49
218031-180313.6133.62
315968-159683.1993.22
414252-142522.8562.88
57542-75421.5111.52
618423-184233.6913.70
极限199971-9997120.03020.646.1020.0520.676.11
2107771-10777121.59321.62
3103754-10375420.78820.83
4106688-10668821.37621.41
591829-9182918.39918.42
6108098-10809821.65821.69
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014921894930734936944928354925624928710.12
211.024843544911004877270.98
单位质量响应值RSD%判断
44765.7644258.350.81数据可信
供试品溶液-F66942批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13024-30240.6110.5718.620.610.5718.70
22937-29370.5940.59
33483-34830.7040.70
41900-19000.3840.38
52955-29550.5970.60
62662-26620.5380.54
10min11646-16460.3330.3420.210.340.3520.46
22107-21070.4260.43
32036-20360.4120.42
41179-11790.2380.24
51657-16570.3350.34
61535-15350.3100.31
15min11913-19130.3870.3261.680.390.3361.83
23019-30190.6100.62
31743-17430.3520.36
4-0.0000.00
51673-16730.3380.34
61224-12240.2470.25
20min13333-33330.6740.4538.820.680.4638.50
21816-18160.3670.38
32297-22970.4640.47
41138-11380.2300.23
51659-16590.3350.34
63140-31400.6350.64
30min12091-20910.4230.6147.950.430.6247.44
23184-31840.6440.65
35749-57491.1621.17
41598-15980.3230.33
52849-28490.5760.58
62668-26680.5390.55
45min15219-52191.0551.0127.371.071.0327.16
25636-56361.1401.15
36772-67721.3691.39
44171-41710.8430.85
55489-54891.1101.12
62788-27880.5640.58
60min112885-128852.6051.8624.322.621.8724.17
28063-80631.6301.65
310960-109602.2162.24
47856-78561.5881.60
58143-81431.6471.66
67193-71931.4541.47
极限187228-8722817.63716.798.1717.6716.828.16
289830-8983018.16418.19
380512-8051216.27916.32
489113-8911318.01918.04
578680-7868015.90915.94
672846-7284614.72914.75
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.014904344933944923604919584925354921360.23
211.024856524922044889280.95
单位质量响应值RSD%判断
44699.0044367.330.53数据可信
供试品溶液-F90166批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14423-44230.8940.878.940.890.879.14
24463-44630.9020.90
34938-49380.9981.00
44027-40270.8140.81
54103-41030.8290.83
63879-38790.7840.78
10min12278-22780.4600.484.640.470.484.63
22453-24530.4960.50
32493-24930.5040.51
42304-23040.4660.47
52408-24080.4870.49
62219-22190.4480.45
15min11381-13810.2790.4234.910.290.4234.87
23452-34520.6980.71
31893-18930.3830.39
41915-19150.3870.39
51967-19670.3980.40
61722-17220.3480.35
20min11831-18310.3700.4110.650.380.4210.86
22077-20770.4200.43
32201-22010.4450.46
42030-20300.4100.42
52307-23070.4660.48
61739-17390.3510.36
30min11888-18880.3820.5019.150.390.5118.89
22668-26680.5390.55
33271-32710.6610.67
42192-21920.4430.45
52441-24410.4930.51
62331-23310.4710.48
45min13259-32590.6590.8421.380.670.8521.20
24228-42280.8540.87
35656-56561.1431.16
43240-32400.6550.67
54353-43530.8800.89
64149-41490.8390.85
60min16404-64041.2941.3216.951.311.3416.91
25923-59231.1971.22
38146-81461.6461.67
45073-50731.0251.04
57500-75001.5161.54
66228-62281.2591.28
极限181366-8136616.44417.494.1116.4717.524.11
290311-9031118.25218.28
387378-8737817.65917.69
490342-9034218.25818.28
585831-8583117.34617.37
683979-8397916.97217.00
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